Prosthetic heart valves

ABSTRACT

Some embodiments described herein include a heart valve replacement system that may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, a prosthetic heart valve of the system includes structural features that securely anchor the prosthetic heart valve to the site of the native heart valve. Such structural features can provide robust migration resistance. In particular implementations, the prosthetic heart valves occupy a smaller delivery profile, thereby facilitating a smaller delivery catheter for advancement to the heart.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Application Ser. No.17/993,573, filed on Nov. 23, 2022, which is a continuation of U.S.application Ser. No. 17/747,507 (U.S. Pat. No. 11,510,777) filed on May18, 2022, which claims the benefit of U.S. Provisional Application Ser.No. 63/308,657, filed Feb. 10, 2022. The disclosures of the priorapplications are considered part of (and are incorporated by referencein) the disclosure of this application.

FIELD OF INVENTION

This disclosure generally relates to prosthetic heart valve systems. Forexample, this disclosure relates to transcatheter deliverable prostheticheart valves that are adapted to be used to replace a sub-optimallyfunctioning native heart valve, including but not limited to a tricuspidvalve.

BACKGROUND

A human heart includes four types of heart valves that are arranged toensure blood flow in specific directions: mitral, tricuspid, aortic andpulmonary valves. The aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart, and prevent blood fromflowing back into left ventricle and right ventricle respectively whenclosed. The mitral and tricuspid valves are atrio-ventricular valves,which are between the atria and the ventricles, and prevent blood fromflowing back into left atrium and right atrium respectively when closed.Conditions of stenosis (when valve does not open fully) as well asregurgitation/insufficiency (when valve does not close properlyresulting in leaks) are recognized as significant contributors tomortality and morbidity.

Some valve replacement systems include valve prostheses that arecompressed into a delivery catheter, also referred to as transcathetervalves, so as to avoid open-heart surgery. Many transcatheter valveprostheses have a tubular frame that may or may not be axisymmetric, andinclude two or more leaflets. While these transcatheter valve prosthesescan be compressed into a catheter, they may still require a largedelivery system (for example, a required catheter size of French). Thisis especially true in case of mitral valve replacement systems andtricuspid valve replacement systems, which often require valveprostheses with a larger footprint.

SUMMARY

Some embodiments described herein include a heart valve replacementsystem that may be delivered to a targeted native heart valve site viaone or more delivery catheters. In some embodiments, a prosthetic heartvalve of the system includes structural features that securely anchorthe prosthetic heart valve to the site of the native heart valve. Suchstructural features can provide robust migration resistance. Inparticular implementations, the prosthetic heart valves occupy a smallerdelivery profile, thereby facilitating a smaller delivery catheter foradvancement to the heart.

In one aspect, this disclosure is directed to a prosthetic heart valveembodiment. The prosthetic heart valve can have a deployed configurationthat includes a main body comprising an inflow end portion and anoutflow end portion; an occluder defining an axis extending between theinflow end and outflow end portions and comprising valve leafletsattached to the main body in an arrangement that: (i) allows blood flowthrough the occluder in a direction from the inflow end portion towardthe outflow end portion and (ii) prevents blood flow through theoccluder in a direction from the outflow end portion toward the inflowend portion; a posterior flap extending transversely to the axis andaway from the outflow end portion of the main body; and a leafletengagement member extending from the main body in a same direction asthe posterior flap, a portion of the leaflet engagement member extendingtoward the inflow end portion and terminating at a free end.

Such a prosthetic heart valve may optionally include one or more of thefollowing features. The area of the main body that the leafletengagement member extends from may be the outflow end portion or amid-body portion located between the inflow end and outflow endportions. The portion of the leaflet engagement member may extend alongan outside of the main body and may be spaced apart from the main body.The posterior flap may extend laterally farther away from the main bodythan the leaflet engagement member. The leaflet engagement member mayinclude a U-shaped wire loop. The leaflet engagement member may be afirst leaflet engagement member that terminates at a first free end, andthe prosthetic heart valve may also include a second leaflet engagementmember extending in the direction from the outflow end portion towardthe inflow end portion and terminating at a second free end. Theprosthetic heart valve may also include an anterior flap extendingtransversely to the axis and away from the outflow end portion of themain body in a direction opposite of the posterior flap. The anteriorflap may be a first anterior flap, and the prosthetic heart valve mayalso include a second anterior flap extending transversely to the axisand away from the outflow end portion of the main body in a samedirection as the first anterior flap. Portions of the first anteriorflap and the second anterior flap may overlap each other when theprosthetic heart valve is deployed. An open space may be defined betweenthe first anterior flap and the second anterior flap when the prostheticheart valve is deployed.

In another aspect, another prosthetic heart valve embodiment isdisclosed herein that includes a main body comprising a first end, asecond end that is opposite of the first end, and an occluder havingvalve leaflets; a first anterior flap extending laterally from thesecond end of the main body; and a second anterior flap extendinglaterally from the second end of the main body in a same direction asthe first anterior flap. The first anterior flap and the second anteriorflap can each include a mid-body portion that is bent at an angle thatdirects terminal end portions of each of the first anterior flap and thesecond anterior flap partially toward the first end of the main body.

Such a prosthetic heart valve can optionally include one or more of thefollowing features. The angle may be between 20° and 60°. Portions ofthe first anterior flap and the second anterior flap may overlap eachother when the prosthetic heart valve is deployed. The prosthetic heartvalve may also include a posterior flap extending laterally away fromthe second end of the main body in a direction laterally opposite of thefirst and second anterior flaps. The posterior flap may include amid-body portion that is bent to direct a terminal end portion of theposterior flap away from the first end of the main body.

In another aspect, another prosthetic heart valve embodiment isdisclosed herein that includes a main body comprising a first end, asecond end that is opposite of the first end, and an occluder havingvalve leaflets, the occluder defining an axis extending between thefirst and second ends; a first anterior flap extending transversely tothe axis and away from the second end of the main body; a secondanterior flap extending transversely to the axis and away from thesecond end of the main body in a same direction as the first anteriorflap; and a covering attached to the first and second anterior flaps.The covering defines a first opening through a terminal end portion ofthe first anterior flap, and a second opening through a terminal endportion of the second anterior flap.

Such a prosthetic heart valve can optionally include one or more of thefollowing features. The first anterior flap and the second anterior flapmay each include a mid-body portion that is bent at an angle thatdirects the terminal end portions of each of the first anterior flap andthe second anterior flap partially toward the first end of the mainbody. The angle may be between 20° and 60°. Portions of the firstanterior flap and the second anterior flap may overlap each other whenthe prosthetic heart valve is deployed. An open space may be definedbetween the first anterior flap and the second anterior flap when theprosthetic heart valve is deployed.

In another aspect, another prosthetic heart valve embodiment isdisclosed herein that includes a main body comprising an inflow endportion and an outflow end portion, a transverse cross-section of themain body having an oval shaped outer profile that defines a majordiameter; an occluder extending between the inflow end and outflow endportions and comprising valve leaflets attached to the main body in anarrangement that: (i) allows blood flow through the occluder in adirection from the inflow end portion toward the outflow end portion and(ii) prevents blood flow through the occluder in a direction from theoutflow end portion toward the inflow end portion, the occluder having acircular cross-sectional shape; an anterior flap extending transverselyto the major diameter and away from the outflow end portion of the mainbody; and a posterior flap extending transversely to the major diameterand away from the outflow end portion of the main body in a directionopposite of the anterior flap.

Such a prosthetic heart valve can optionally include one or more of thefollowing features. The prosthetic heart valve may also include aleaflet engagement member extending from the main body. A portion of theleaflet engagement member may extend toward the inflow end portion andterminating at a free end. The leaflet engagement member may extend in asame direction as the posterior flap. The anterior flap is a firstanterior flap, and the prosthetic heart valve may also include a secondanterior flap extending transversely to the major diameter and away fromthe outflow end portion of the main body in a same direction as thefirst anterior flap.

Any of the prosthetic heart valves described herein may optionallyinclude one or more of the following additional features. In someembodiments, portions of the first anterior flap and the second anteriorflap overlap each other. The prosthetic tricuspid valve may also includea posterior flap extending laterally from the end of the main body in anopposite direction as the first and second anterior flaps. In someembodiments, the first and second anterior flaps extend fartherlaterally than the posterior flap. In particular embodiments, the firstand second anterior flaps in combination are wider than the posteriorflap. A framework of the prosthetic tricuspid valve (that comprises themain body, the first and second anterior flaps, and the posterior flap)may be made of a single, unitary material that was cut and expanded. Insome embodiments, a distal tip portion of the posterior flap extendsalong an axis that is at a non-zero angle relative to a portion of theposterior flap that extends directly from the main body. In someexamples, having the portions of the first anterior flap and the secondanterior flap that overlap each other increases a bending resistance ofthe first anterior flap and the second anterior flap in combination ascompared to the first anterior flap and the second anterior flapindividually. Having the portions of the first anterior flap and thesecond anterior flap as separate members can configure the prosthetictricuspid valve to have a pacemaker lead pass through the prosthetictricuspid valve between the first and second anterior flaps. Theprosthetic tricuspid valve may also include one or more additionalanterior flaps extending laterally from the end of the main body in thesame direction as the first and second anterior flaps. The prosthetictricuspid valve may also include two or more posterior flaps extendinglaterally from the end of the main body in an opposite direction as thefirst and second anterior flaps.

A deployment system may be used in combination with the prosthetictricuspid valve. Such a deployment system may include a sheath catheterdefining a first lumen, an outer proximal catheter slidably disposedwithin the first lumen and defining a second lumen, and an inner distalcatheter slidably disposed within the second lumen. The prosthetictricuspid valve may be disposed within the first lumen in a low profiledelivery configuration and may be releasably attached to one or both ofthe outer proximal catheter and the inner distal catheter. In someembodiments, the main body is releasably attached to outer proximalcatheter, and/or the first and second anterior flaps are releasablyattached to the inner distal catheter. The prosthetic tricuspid valvemay also include a posterior flap extending laterally from the end ofthe main body in an opposite direction as the first and second anteriorflaps. The posterior flap may be disposed within the first lumen whilenot being directly attached to the deployment system. In someembodiments, the first and second anterior flaps are individuallyreleasably attached to the inner distal catheter.

In another aspect, this disclosure is directed to a method of treating adeficiency of a native tricuspid valve. The method includes implanting aprosthetic tricuspid valve in the native tricuspid valve. The prosthetictricuspid valve may be configured in any of the arrangements describedherein. In some embodiments, the implanting comprises: (i) positioningthe posterior flap in a posterior region of a right ventricle, and (ii)positioning the first and second anterior flaps in a right ventricularoutflow tract (“RVOT”) of the right ventricle.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 shows a sectional view of a human heart including four heartvalves (mitral valve, tricuspid valve, aortic valve, and pulmonaryvalve) that allow blood flow through specific pathways. The mitral andtricuspid valve are arranged to prevent backflow of blood into leftatrium and right atrium respectively when the left and right ventriclecontract respectively.

FIG. 2 shows a top view of the tricuspid valve of FIG. 1 and includingthree native leaflets: anterior, posterior and septal.

FIG. 3 shows another sectional view of a human heart including the fourchambers (right atrium, right ventricle, left atrium, and leftventricle) and major conduits that deliver blood to the heart andtransport blood away from the heart.

FIG. 4 shows a schematic view of the right side of the heart of FIG. 3 ,including the right atrium (“RA”), right ventricle (“RV”), and rightventricle outflow tract (“RVOT”), in accordance with some nativeanatomies.

FIG. 5 shows another schematic view of the right side of the heart ofFIG. 3 , including the RA, RV, and RVOT, in accordance with some nativeanatomies.

FIG. 6 shows a side view of a frame of an example prosthetic heart valvein accordance with some embodiments described herein.

FIG. 7 shows a side view of an example prosthetic heart valve thatincludes the frame of FIG. 6 .

FIG. 8 shows a top view of the frame of FIG. 6 .

FIG. 9 shows a top view of the prosthetic heart valve of FIG. 7 .

FIG. 10 schematically shows the frame of FIG. 6 positioned in an examplenative tricuspid heart valve location.

FIG. 11 schematically shows a posterior leaflet of a native tricuspidvalve and the walls of a right atrium and right ventricle in accordancewith some native anatomies.

FIG. 12 schematically shows a portion of the frame of FIG. 6 positionedin the example anatomy of FIG. 11 .

FIG. 13 shows a top view of the frame of FIG. 6 and two cut-planesthrough the frame.

FIG. 14 schematically shows a cross-sectional portion of the frame ofFIG. 13 , taken along a first cut-plane of FIG. 13 , and positioned inthe example anatomy of FIG. 11 .

FIG. 15 schematically shows a cross-sectional portion of the frame ofFIG. 13 , taken along a second cut-plane of FIG. 13 , and positioned inthe example anatomy of FIG. 11 .

FIG. 16 schematically shows a side view of an example prosthetictricuspid valve in accordance with some embodiments.

FIG. 17 shows a side view of the example prosthetic tricuspid valve ofFIG. 16 .

FIG. 18 schematically shows a side view of another example prosthetictricuspid valve in accordance with some embodiments.

FIG. 19 shows a side view of the example prosthetic tricuspid valve ofFIG. 18 .

FIG. 20 schematically shows a side view of another example prosthetictricuspid valve in accordance with some embodiments.

FIG. 21 shows a side view of the example prosthetic tricuspid valve ofFIG. 20 .

FIG. 22 schematically shows a side view of another example prosthetictricuspid valve in accordance with some embodiments.

FIG. 23 shows a side view of the example prosthetic tricuspid valve ofFIG. 22 .

FIG. 24 schematically shows an example prosthetic heart valve containedwithin a delivery sheath.

FIG. 25 schematically shows a first stage of deployment of theprosthetic heart valve from the delivery sheath of FIG. 24 .

FIG. 26 schematically shows a second stage of deployment of theprosthetic heart valve from the delivery sheath of FIG. 24 .

FIG. 27 schematically shows a third stage of deployment of theprosthetic heart valve from the delivery sheath of FIG. 24 .

FIG. 28 schematically shows the prosthetic heart valve of FIG. 24 in afully deployed arrangement.

FIG. 29 schematically shows a posterior leaflet of a native tricuspidvalve and the walls of a right atrium and right ventricle in accordancewith some native anatomies.

FIG. 30 schematically shows a portion of the frame of FIG. 6 positionedin the example anatomy of FIG. 29 .

FIG. 31 shows a top view of the frame of FIG. 6 and two cut-planesthrough the frame.

FIG. 32 schematically shows a cross-sectional portion of the frame ofFIG. 31 , taken along a first cut-plane of FIG. 31 , and positioned inthe example anatomy of FIG. 29 .

FIG. 33 schematically shows a cross-sectional portion of the frame ofFIG. 31 , taken along a second cut-plane of FIG. 31 , and positioned inthe example anatomy of FIG. 29 .

FIG. 34 is a first side view of another example prosthetic heart valvein accordance with some embodiments.

FIG. 35 is a second side view of the prosthetic heart valve of FIG. 34 .

FIG. 36 is a first view of example anterior flaps of another exampleprosthetic heart valve in accordance with some embodiments.

FIG. 37 is a second view of the example anterior flaps of FIG. 36 .

FIG. 38 is a top view of another example prosthetic heart valve inaccordance with some embodiments, and illustrates a pacemaker leadextending through an opening defined between the two anterior flaps ofthe prosthetic heart valve.

FIG. 39 schematically illustrates an example shape of a tricuspid valveannulus in accordance with some native anatomies.

FIG. 40 schematically illustrates an example prosthetic heart valve inaccordance with some embodiments within the tricuspid valve annulus ofFIG. 39 .

FIG. 41 is a top view of a frame of an example prosthetic heart valvethat is configured like the schematic example of FIG. 40 .

FIG. 42 shows a top view of an example prosthetic heart valve thatincludes the frame of FIG. 41 .

DETAILED DESCRIPTION

Some embodiments described herein include a heart valve replacementsystem that may be delivered to a targeted native heart valve site viaone or more delivery catheters. In some embodiments, a prosthetic heartvalve of the system includes structural features that securely anchorthe prosthetic heart valve to the site of the native heart valve. Suchstructural features can provide robust migration resistance. Inparticular implementations, the prosthetic heart valves occupy a smallerdelivery profile, thereby facilitating a smaller delivery catheter foradvancement to the heart.

Referring to FIG. 1 , the concepts described herein regarding the heartvalve replacement systems can be implemented in prosthetic valve designsthat are intended for use at any of the four heart valves that allowblood flow through a specific pathway: mitral valve, tricuspid valve,aortic valve and the pulmonary valve. FIG. 2 depicts, for example, atargeted site at a tricuspid valve 10 of the heart. The tricuspid valve10 includes an anterior leaflet 11 a, a posterior leaflet 11 p, and aseptal leaflet 11 s, and an annulus 12. In some circumstances, thetricuspid valve 10 may undergo stenosis or anatomical changes that causetricuspid regurgitation, such as instances in which the distance betweenthe anterio-septal commissure and the anterio-posterior commissure ofthe native tricuspid valve increases with the progression of a diseasedstate due to dilation of the annulus 12 of the tricuspid valve 10.

FIG. 3 illustrates a longitudinal sectional view of a human heart 1 thatshows the four chambers (right atrium, right ventricle, left atrium, andleft ventricle) and the major conduits that deliver blood to the heart 1and transport blood away from the heart 1. The tricuspid valve 10 islocated between the right atrium and the right ventricle. Blood flowsfrom the right atrium to the right ventricle through the tricuspid valve10. The blood exits the right ventricle and enters the main pulmonaryartery (“MPA”) via the RVOT that is adjacent to the tricuspid valve 10.

FIGS. 4 and 5 schematically illustrate the right side of the heart 1,including the right atrium, right ventricle, and tricuspid valve 10therebetween. Naturally, there is anatomical variability among the humanpopulation. FIGS. 4 and 5 depict some of the anatomical variability. Inparticular, FIG. 4 shows a heart 1 a that includes the presence of aposterior shelf 11. In contrast, FIG. 5 shows a heart 1 b with a lack ofany such posterior shelf. Some human hearts (such as the heart 1 a) havea posterior shelf 11, but some human hearts (such as the heart 1 b) donot have a distinct posterior shelf. Fortunately, the prosthetictricuspid valves disclosed herein can be implanted in the nativetricuspid valve 10 of both types of anatomies (e.g., both the heart 1 awith the posterior shelf 11, and the heart 1 b without the posteriorshelf).

The posterior shelf 11, when present, provides an anatomical structurethat can be used advantageously for the anchorage of a prosthetictricuspid valve (as described further herein). When no such posteriorshelf is present (e.g., as shown in FIG. 5 ), robust anchorage of aprosthetic tricuspid valve at the site of the native tricuspid valve 10is more challenging. Nevertheless, as described further herein, theprosthetic tricuspid valves described herein can be successfully used insuch a case.

FIGS. 6-9 illustrate an example prosthetic tricuspid valve 100 (orsimply “valve 100”) in accordance with some example embodiments of thisdisclosure. The valve 100 includes a frame 102 and a covering 104attached to the frame 102. FIGS. 6 and 8 show the frame 102 alone. FIGS.7 and 9 show the covering 104 attached to the frame 102 (which is thefull configuration of the valve 100).

The frame 102 comprises a cellular structure that provides mechanicalsupport for the shape and structures of the valve 100. In someembodiments, the frame 102 is made from nitinol (NiTi), stainless steel,cobalt chromium, MP35N, titanium, polymeric materials, otherbiocompatible materials, or any combination thereof. Some or all partsof the frame 102 may be covered by the covering 104. The frame 102 canbe made of a laser cut, expanded, and shape-set material in someembodiments. In some embodiments, the precursor material is tubularNiTi, a NiTi sheet, or other suitable types of precursor materials.

The covering 104 may made of a biocompatible polymer material (e.g.,expanded polytetrafluoroethylene (ePTFE), UHMWPE (ultra-high molecularweight polyethylene), nylon, polyester (e.g., DACRON), or anothersynthetic material), natural tissues (e.g., bovine, porcine, ovine, orequine pericardium), or any combination thereof. The covering 104 can beattached to the frame 102 by suturing, using clips, and/or any othersuitable attachment process.

The valve 100 includes a main body 106. The main body 106 includes anoccluder 110 that defines a central axis 101. The occluder 110 hasflexible leaflets 111 a, 111 b, and 111 c (collectively 111 a-c) thatcause the occluder 110 to function as a one-way valve (in a manner likea native tricuspid valve). The occluder 110 defines a circular inletwhere the edges of leaflets 111 a-c are attached to the frame 102. Otherside edges of the leaflets 111 a-c are attached to posts 112 a, 112 b,and 112 c of the frame 102. The leaflets 111 a-c also have distal freeedges that are coaptable with each other to facilitate the opening andsealing of the occluder 110.

The main body 106 of the valve 100 includes an inflow end portion 102 i,a mid-body portion 102 m, and an outflow end portion 102 o. The inflowend portion 102 i includes a series of arch shapes in the frame 102,circumscribing the axis 101 of the occluder 110. The occluder leaflets111 a-c allow blood to directionally flow through the occluder 110 fromthe inflow end portion 102 i to the outflow end portion 102 o. Theleaflets 111 a-c of the occluder 110 close against each other (e.g.,coapt) to prevent blood flow in the other direction (to prevent bloodflow from the outflow end portion 102 o to the inflow end portion 102i).

The embodiments of the valve 100 depicted in this disclosure employthree occluder leaflets 111 a-c, which is referred to as tri-leafletoccluder. The occluder 110 of the valve 100 can optionally employconfigurations other than a tri-leaflet occluder. For example,bi-leaflet, quad-leaflet, or mechanical valve constructs can be used insome embodiments. In particular implementations described herein, theflexible leaflets 111 a-c are made of natural tissues such as porcine orbovine or equine or ovine pericardium. In such embodiments, the tissuesare chemically cross-linked using glutaraldehyde or formaldehyde, orother aldehydes commonly used as crosslinking agents. In otherembodiments, the flexible leaflets 111 a-c are made of polymers such aspolyurethane, polyester (DACRON) or expanded polytetrafluoroethylene(ePTFE). In some embodiments, the flexible leaflets 111 a-c are attachedto structural frame 102 using sutures that could be made of materialsincluding but not limited to UHMWPE, nylon, or polyester (e.g., DACRON).

The valve 100 also includes a first anterior flap 120 a, a secondanterior flap 120 b, and a posterior flap 130. The frame 102 and thecovering 104 combine to form the anterior flaps 120 a-b and theposterior flap 130. The frame 102 provides the structure of the anteriorflaps 120 a-b and the posterior flap 130, and the covering 104 providesocclusion. While the depicted embodiment includes two anterior flaps 120a-b, in some embodiments one, three, four, or more than four anteriorflaps can be included. While the depicted embodiment includes a singleposterior flap 130, in some embodiments two, three, four, or more thanfour posterior flaps can be included.

The anterior flaps 120 a-b and the posterior flap 130 extend away fromthe outflow end portion 102 o of the main body 106 in oppositedirections away from the axis 101. That is, the posterior flap 130extends directionally opposite from the extension direction of the firstand second anterior flaps 120 a-b. In some embodiments, the posteriorflap 130 extends 180° opposite from the extension direction of the firstand second anterior flaps 120 a-b. In particular embodiments, theanterior flaps 120 a-b and the posterior flap 130 extend away from theoutflow end portion 102 o of the main body 106 transverse to the axis101 of the occluder 110.

In the depicted embodiment, the posterior flap 130 includes a firstportion 130 a and a second portion 130 b that are arranged at an anglein relation to each other. The first portion 130 a extends away from theoutflow end portion 102 o of the main body 106 generally transverse tothe axis 101 of the occluder 110. The second portion 130 b of theposterior flap 130 extends from the first portion 130 a. In the depictedembodiment, the second portion 130 b extends generally parallel to theaxis 101 of the occluder 110. The angle defined between the firstportion 130 a and the second portion 130 b can be in a range of 80° to100°, or 70° to 110°, or 60° to 120°, or 50° to 130°, or 40° to 140°,without limitation.

The first anterior flap 120 a and the second anterior flap 120 b eachextend in the same direction, which is opposite of the direction thatthe posterior flap 130 extends. In the depicted embodiment, portions ofthe first anterior flap 120 a and the second anterior flap 120 b overlapeach other. An advantage of having the two separate anterior flaps 120a-b (rather than a single larger anterior flap) is that the anteriorflap portion of the valve 100 can be radially compressed to a smallerprofile for transcatheter delivery by the virtue of having the twoseparate anterior flaps 120 a-b (as compared to having a single largeranterior flap).

In some embodiments, the first and second anterior flaps 120 a-b extendinto the RVOT and overlap one axially on top of the other. Thisarrangement is functionally akin to a cantilevered beam arrangement.With the first and second anterior flaps 120 a-b overlapping on eachother, the bending resistance of the first and second anterior flaps 120a-b is increased (as compared to a single flap or non-overlappingflaps). This arrangement enables an advantageous extent of rigidity,without having to use framework members that are larger incross-section. That is, the overlapping arrangement of the first andsecond anterior flaps 120 a-b allow for the use of smaller frameworkmembers, which in turn importantly allows for a smaller collapseddelivery size (diameter). In other words, overlapping arrangement of thefirst and second anterior flaps 120 a-b provides a support structurethat is thicker without having to use a material with higher wallthickness (from which the framework is created); ultimately providingthe bending stiffness or rigidity that keeps the valve 100 stable whenRV pressure acts on the valve 100.

In the depicted embodiment, an open passage 122 (e.g., see FIG. 8 ) isdefined between the first anterior flap 120 a and the second anteriorflap 120 b. This is also shown in FIG. 38 . The open passage 122 can beused, for example, for passing a pacemaker lead through the valve 100,without disturbing the functioning of the occluder 110. Accordingly, thevalve 100 can facilitate the pass-through of the pacemaker lead whilestill providing sealing to prevent tricuspid valve regurgitation fromthe RV to the RA. In some cases, the pacemaker lead is pre-existing andthe valve 100 is implanted subsequently (with the open passage 122 beingused to receive the pacemaker lead). In other cases, the valve 100 canbe pre-existing and the pacemaker lead can be subsequently passedthrough the open passage 122.

The valve 100 also includes one or more leaflet engagement members 140.In the depicted embodiment, the valve 100 includes two leafletengagement members: a first leaflet engagement member 140 a and a secondengagement member 140 b. In the depicted embodiment, the leafletengagement members 140 a-b extend from the outflow end portion 102 o ofthe main body 106. In some embodiments, the leaflet engagement members140 a-b extend from the mid-body portion 102 m of the main body 106.

The leaflet engagement members 140 a-b extend from the frame 102 andbend toward the inflow end portion 102 i of the main body 106. In otherwords, a portion of each leaflet engagement member 140 a-b extendstoward the inflow end portion 102 i of the main body 106. A space,groove, or slot is defined between the leaflet engagement members 140a-b and the outer surface of the frame 102 (with the covering 104 beingpresent on the frame 102 and leaflet engagement members 140 a-b). Asdescribed further below, the space, groove, or slot receives andmechanically captures/holds a portion of a native leaflet to providemigration resistance for the valve 100.

In the depicted embodiment, the leaflet engagement members 140 a-bextend from the frame 102 of the main body 106 in the same direction asthe posterior flap 130. The posterior flap 130 extends away from themain body 106 farther than the leaflet engagement members 140 a-b. Asdescribed further below, various other arrangements of the leafletengagement members 140 a-b and the posterior flap 130 are alsoenvisioned and within the scope of this disclosure.

The leaflet engagement members 140 a-b may be U-shaped wire loops, as inthe depicted embodiment. The wire loops that make up the leafletengagement members 140 a-b can be continuous with the wire members ofthe frame 102.

In the depicted embodiment, the leaflet engagement members 140 a-bterminate at free ends. Accordingly, the leaflet engagement members 140a-b point toward the inflow end portion 102 i of the main body 106, withthe free ends of the leaflet engagement members 140 a-b being theclosest to the inflow end portion 102 i. This arrangement defines thespace, groove, or slot receives and mechanically captures/holds aportion of a native leaflet to provide migration resistance for thevalve 100.

FIG. 10 depicts the valve 100 implanted in the heart 1 b. As per FIG. 5, the heart 1 b does not always naturally include a distinct posteriorshelf in the right ventricle (“RV”) below the annulus 12 of the nativetricuspid valve 10. However, as described further below, the valve 100is structured to induce an anchoring location that resembles a posteriorshelf once the valve 100 is fully deployed. The valve 100 is shown herewithout the covering 104 to provide additional clarity of theorientation of the valve 100 relative to the native tricuspid valve 10and the other structures of the heart 1 b.

In FIG. 10 , it can be seen that the posterior leaflet 11 p and/or theseptal leaflet 11 s is captured and held by the leaflet engagementmember(s) 140. This provides anchorage and migration resistance of thevalve 100. Additionally, the posterior flap 130 of the valve 100atraumatically presses against the wall of the RV just below the annulus12 of the native tricuspid valve 10. In that manner, the posterior flap130 nestles against the wall of the RV just below the annulus 12 andprovides additional anchorage and migration resistance of the valve 100.Further, the anterior flap(s) 120 provide anchorage for the valve 100 byopposing against the wall of the RV below the anterior leaflet 11 a ofthe tricuspid valve 12, and by opposing against the wall that definesthe inlet to the RVOT. For example, during contraction of the RV, theanterior flap(s) 120 become pressed against the wall of the RVOT to helpprevent the valve 100 from being pushed into the RA because of thepressure differential between the RV and RA during contraction of theRV.

FIGS. 11 and 12 provide the bases for additional information regardinghow the valve 100 can provide robust anchorage and migration resistanceeven in the case of the anatomy of the heart 1 b that, from a naturalstandpoint, exhibits no distinct posterior shelf (e.g., as compared tothe heart 1 a of FIG. 4 ). In FIG. 12 , the valve 100 is implanted inthe tricuspid valve 10 of the heart 1 b.

As illustrated in FIG. 12 , the valve 100 anchors in relation to theposterior region of the native tricuspid valve 10 using opposing forces.That is, a first force F1 (as indicated by the arrow F1) results becausethe posterior leaflet 11 p and/or the septal leaflet 11 s captured andheld by the leaflet engagement member(s) 140. Additionally, a secondforce F2 (as indicated by the arrows F2) results because the posteriorflap bears against the wall of the RV beneath the annulus 12 of thetricuspid valve 10. The forces F1 and F2 act in opposite directions ofeach other. It can be said that force F1 pulls on the posterior leaflet11 p and/or the septal leaflet 11 s and force F2 pushes on the wall ofthe RV. This push-pull arrangement of opposing forces results in asecure anchorage and robust migration resistance of the valve 100relative to the native tricuspid valve 10.

FIG. 13 is another top view of the frame 102 of the valve 100. Twocut-planes are indicated by the dashed lines. The first cut-plane 14corresponds to the view of FIG. 14 . This view passes through the firstleaflet engagement member 140 a. The second cut-plane 15 corresponds tothe view of FIG. 15 . This view is along the frame 102 between theleaflet engagement members 140 a and 140 b.

As shown in FIG. 14 , the posterior leaflet 11 p and/or the septalleaflet 11 s captured and held by the first leaflet engagement member140 a. That is, the posterior leaflet 11 p and/or the septal leaflet 11s is held captive within the space between the first leaflet engagementmember 140 a and the main body 106. While it is not visible in thisview, the same is true about the second leaflet engagement member 140 b.That is, the posterior leaflet 11 p and/or the septal leaflet 11 s isheld captive within the space between the second leaflet engagementmember 140 b and the main body 106.

As shown in FIG. 15 , in the depicted example implementation theposterior leaflet 11 p and/or the septal leaflet 11 s is abutting theframe 102 along the portion of the main body 106 that extends betweenthe leaflet engagement members 140 a and 140 b. Of course, in realitythe valve 100 includes a covering 104 on the frame 102. Therefore, theposterior leaflet 11 p and/or the septal leaflet 11 s would be actuallyabutting the covering 104 that is on the frame 102. The arrangementdepicted in FIG. 15 occurs in some cases. In other cases (such asdepicted in FIG. 33 ), portions of the posterior leaflet 11 p and/or theseptal leaflet 11 s between the leaflet engagement members 140 a and 140b do not reside so closely to the frame 102 as is depicted in FIG. 15 .

FIGS. 16-23 schematically illustrate four different variations of thevalve 100. The differences between the four different variations concernthe arrangement of the posterior flap 130 and the leaflet engagementmember(s) 140. Otherwise, in general, the four different variations ofthe valve 100 (referred to as valve 100 a, valve 100 b, valve 100 c, andvalve 100 d) share the features of the valve 100 as described herein.

FIGS. 16 and 17 illustrate an example valve 100 a. The valve 100 aincludes the main body 106 a (and covering 104), the occluder 110, theanterior flaps 120 a-b, the posterior flap 130 a, the first leafletengagement member 140 aa and the second engagement member 140 ab. Fromthe top view of FIG. 17 , it can be seen that the posterior flap 130 aextends away from the main body 106 a between the first leafletengagement member 140 aa and the second engagement member 140 ab. Thefirst leaflet engagement member 140 aa is located on one side of theposterior flap 130 a, and the second engagement member 140 ab is locatedon the other side of the posterior flap 130 a.

FIGS. 18 and 19 illustrate an example valve 100 b. The valve 100 bincludes the main body 106 b (and covering 104), the occluder 110, theanterior flaps 120 a-b, the posterior flap 130 b, the first leafletengagement member 140 ba and the second engagement member 140 bb. Fromthe top view of FIG. 19 , it can be seen that the first leafletengagement member 140 ba and the second engagement member 140 bb extendaway from the main body 106 b within the outer periphery of theposterior flap 130 b. As shown in FIG. 19 , the posterior flap 130 b iswider than the combined widths of the first leaflet engagement member140 ba and the second engagement member 140 bb.

FIGS. 20 and 21 illustrate an example valve 100 c. The valve 100 cincludes the main body 106 c (and covering 104), the occluder 110, theanterior flaps 120 a-b, the posterior flap 130 c, and a single leafletengagement member 140 c. From the top view of FIG. 21 , it can be seenthat the single leaflet engagement member 140 c extends away from themain body 106 c within the outer periphery of the posterior flap 130 c.The posterior flap 130 c is more than twice of the width of the singleleaflet engagement member 140 c. The single leaflet engagement member140 c is centered in relation to the posterior flap 130 c. In otherembodiments, the single leaflet engagement member 140 c is not centeredin relation to the posterior flap 130 c.

FIGS. 22 and 23 illustrate an example valve 100 d. The valve 100 dincludes the main body 102 d (and covering 104), the occluder 110, theanterior flaps 120 a-b, the posterior flap 130 d, and a single leafletengagement member 140 d. From the top view of FIG. 23 , it can be seenthat the single leaflet engagement member 140 d extends along an entirewidth of the posterior flap 130 d (from one edge of the posterior flap130 d to an opposite edge of the posterior flap 130 d). The singleleaflet engagement member 140 d extends from the posterior flap 130 d(rather than extending from the main body 106 d). In other embodiments,the single leaflet engagement member 140 d extends from the main body106 d.

FIGS. 24-28 are a series of schematic illustrations that depict themajor steps of a deployment process of the valve 100. The valve 100 isdeployable using a transcatheter technique. While the deployment of thevalve 100 is described in these figures in the context of a tricuspidvalve replacement, the valve 100 can also be used for mitral, aortic andpulmonary valves replacements. Similar steps to deploy the valve 100 canbe followed for the mitral, aortic and pulmonary valves.

As shown in FIG. 24 , the valve 100 is initially contained within adelivery sheath catheter 200, and is around an inner catheter 210. Thesheath catheter 200 and/or the inner catheter 210 can be steerable ordeflectable in some embodiments. In some embodiments, the inner catheter210 can be advanced over a guidewire.

The valve 100 is radially compressed to a low-profile deliveryconfiguration while within the sheath catheter 200. In some embodiments,the valve 100 (or portions thereof are wrapped or folded around theinner catheter 210. For example, in some embodiments the anterior flaps120 a-b are wrapped around the inner catheter 210. The valve 100 canself-expand as emergence from the sheath catheter 200 (or relief fromother types of containment as described below) takes place.

In some embodiments, when the valve 100 is in its collapsed deliveryconfiguration within the delivery sheath catheter 200, the portions ofthe valve 100 are arranged relative to each other as follows. The firstand second anterior flaps 120 a-b (which can be wrapped on each other)are distal-most. The occluder portion (or valve core) with the flexibleleaflets is proximal-most within the delivery sheath catheter 200. Theleaflet engager(s) 140 and the posterior anchoring flap 130 are arrangedbetween the distal-most first and second anterior flaps 120 a-b and theproximal-most occluder portion.

In some embodiments, the system shown in FIG. 24 is advanced toward thepatient's right atrium via either trans-jugular vein access ortrans-femoral vein access. While a trans-jugular vein approach willaccess the right atrium through the superior vena cava, a trans-femoralvein approach will access the right atrium through the inferior venacava. In the arrangement of FIG. 24 , the outer deflectable sheathcatheter 200 may be advanced and deflected to point the system towardsthe tricuspid annular plane.

In FIG. 25 , the leaflet engagement member(s) 140 is/are released fromcontainment within the sheath catheter 200. This can be achieved byeither advancing the inner catheter 210 while holding the sheathcatheter 200 stationary, or by pulling the sheath catheter 200proximally while holding the inner catheter 210 stationary.

The leaflet engagement member(s) 140 tend to reconfigure to a naturalshape or configuration when released from containment. That is, whenreleased from containment, the leaflet engagement member(s) 140reconfigure so that an end portion of the leaflet engagement member(s)140 extends proximally toward the inflow end of the valve 100. As thereconfiguring of the leaflet engagement member(s) 140 takes place (toarrive at the shape shown in FIG. 25 ), the posterior leaflet 11 pand/or the septal leaflet 11 s is captured by the leaflet engagementmember(s) 140. The captured portion of the posterior leaflet 11 p and/orthe septal leaflet 11 s is held captive within the groove or spacedefined by the leaflet engagement member(s) 140. Capturing of theleaflet within the leaflet engagement member(s) 140 may be furtherfacilitated by manipulations of the entire delivery system relative tothe valve annulus and native leaflets, and also guided by imaging suchas ultrasound, fluoroscopy, CT scanning, MRI or other imagingmodalities.

In FIG. 26 , the posterior flap 130 has been released from radialcontainment. In the depicted embodiment, the release of the posteriorflap 130 is achieved by distally advancing the inner catheter 210. Whenthat is performed, a radial containment member 211 attached to the innercatheter 210 is disengaged from the posterior flap 130. This allows theposterior flap 130 to reconfigure to a natural shape or configurationwhen released from containment. The deployed posterior flap 130 willbecome positioned in the posterior shelf area, or will abut against awall of the right ventricle to form a pseudo posterior shelf (if theheart does not naturally have a posterior shelf).

In FIG. 27 , the anterior flaps 120 a-b are allowed to expand radiallyoutward toward their natural shape. This can be achieved by loosening acontrol wire 212 that extends from the inner catheter 210 to theanterior flaps 120 a-b. In some embodiments, the inner catheter 210 canalso be withdrawn proximally in order to allow the anterior flaps 120a-b to extend toward their natural shape. In some embodiments, there aretwo control wires 212. Each one of the anterior flaps 120 a-b can haveits own control wire 212. In such a case, each one of the anterior flaps120 a-b can be deployed separately from each other.

In FIG. 28 , the main body of the valve 100 is unsheathed, or releasedfrom its containment within the sheath catheter 200. The sheath catheter200 can be pulled proximally off the valve 100 to accomplish this. Whenthe unsheathing happens, the main body of the valve 100 radially expandsto its fully deployed size within the annulus of the tricuspid valve.The sheath catheter 200 and the inner catheter 210 can then be removed,leaving the valve 100 to function in place of the native tricuspidvalve. The frame 102 with its covering 104 acts as a sealing skirt. Inaddition, as described further below, the anterior flaps 120 a-b alsoprovide sealing (in addition to anchoring in the RVOT). In someembodiments, portions of the prosthetic valve 100 include an outerexternal anchoring skirt that extends beyond the occluder portion by 0.1mm to 25 mm or preferably by 0.1 mm to 10 mm.

FIG. 29 shows a portion of the heart 1 a that naturally includes theposterior shelf 11 (see also FIG. 4 ). In such a case, as shown in FIG.30 , the posterior flap 130 of the valve 100 extends into the area ofthe posterior shelf 11 and abuts the wall of the RV just below theannulus 12 of the tricuspid valve 10. In addition, the leafletengager(s) 140 may capture and retain the posterior leaflet 11 p and/orthe septal leaflet 11 s. The combination of the anchoring provided bythe posterior flap 130 plus the potential attachment of the leafletengager(s) 140 to the posterior leaflet 11 p and/or the septal leaflet11 s provides robust migration resistance.

FIG. 31 is another top view of the frame 102 of the valve 100. Twocut-planes are indicated by the dashed lines. The first cut-plane 32corresponds to the view of FIG. 32 . This view passes through the firstleaflet engagement member 140 a. The second cut-plane 33 corresponds tothe view of FIG. 33 . This view is along the frame 102 between theleaflet engagement members 140 a and 140 b.

As shown in FIG. 32 , the posterior leaflet 11 p and/or the septalleaflet 11 s captured and held by the first leaflet engagement member140 a. That is, the posterior leaflet 11 p and/or the septal leaflet 11s is held captive within the space between the first leaflet engagementmember 140 a and the main body 106. While it is not visible in thisview, the same is true about the second leaflet engagement member 140 b.That is, the posterior leaflet 11 p and/or the septal leaflet 11 s isheld captive within the space between the second leaflet engagementmember 140 b and the main body 106.

As shown in FIG. 33 , in the depicted example implementation the portionof the posterior leaflet 11 p and/or the septal leaflet 11 s that isbetween the leaflet engagement members 140 a and 140 b is not heldcaptive against the main body 106. The arrangement depicted in FIG. 33occurs in some cases. In other cases (such as depicted in FIG. 15 ),portions of the posterior leaflet 11 p and/or the septal leaflet 11 sreside closely to the main body 106.

FIGS. 34 and 35 show two side views of another example embodiment of thevalve 100. The valve 100 includes a main body 106 within which theoccluder 110 resides. The occluder 110 defines the central longitudinalaxis 101.

In the depicted embodiment, the first anterior flap 120 a and the secondanterior flap 120 b each include a mid-body portion 124 that is bent atan angle so as to direct terminal end portions of the anterior flaps 120a-b toward the inlet end of the main body 106. In some embodiments, theanterior flaps 120 a-b initially extend away from the main body 106substantially perpendicularly (e.g., within 80° to 100°) to the centralaxis 101. Then, at the mid-body portion 124, the anterior flaps 120 a-bhave a bend that defines an angle θ in a range of between 200 to 600, or30° to 600, or 30° to 70°, or 400 to 600, or 40° to 700, or 40° to 50°,without limitation.

The bends in the mid-body 106 of the anterior flaps 120 a-b can allowthe anterior flaps 120 a-b to conform to the contours of the wall thatdefines the RVOT. Accordingly, the bent anterior flaps 120 a-b canreduce the potential of the anterior flaps 120 a-b to restrict bloodflow through the RVOT in some cases.

FIGS. 36 and 37 show two additional views of another example embodimentof the valve 100. The depicted embodiment includes an opening 126 a thatis defined by the covering 104 located at a terminal end portion of thefirst anterior flap 120 a. Additionally, the covering 104 on the secondanterior flap 120 b defines an opening 126 b at a terminal end portionof the second anterior flap 120 b.

The openings 126 a-b in the end portions of the anterior flaps 120 a-ballow blood to flow through the anterior flaps 120 a-b (via the openings126 a-b). This can be beneficial because in some implementations theanterior flaps 120 a-b extend into the RVOT. Accordingly, such openings126 a-b may in some cases reduce the potential of the anterior flaps 120a-b to restrict blood flow through the RVOT.

FIG. 39 schematically illustrates an annulus 12 of a typical tricuspidvalve 10. The shape of the annulus 12 of many tricuspid valves 10 is notcircular. Often, as depicted here, shape of the annulus 12 is oblong orovoidal (oval shaped). That is, the distance between the posterior andanterior regions of the annulus 12 is longer than the distance betweenthe septal and lateral regions of the annulus 12. Accordingly, it can besaid that the annulus 12 defines a major diameter 16 between theposterior and anterior regions, and a minor diameter 18 between theseptal and lateral regions of the annulus 12.

FIG. 40 schematically illustrates an example embodiment of the valve 100implanted in the annulus 12 of the typical tricuspid valve 10. In thisembodiment of the valve 100, the main body 106 has an ovular outercross-sectional shape. In contrast, the occluder 110 within the mainbody 106 has a circular cross-sectional shape.

The oval shaped main body 106 of the valve 100 has a major diameter 108and a minor diameter 109. The anterior flaps 120 a-b and the posteriorflap 130 extend from the main body 106 along a direction that istransverse to the major diameter 108 of the oval shaped main body 106.In some embodiments, the anterior flaps 120 a-b and/or the posteriorflap 130 extend from the main body 106 substantially orthogonally orperpendicularly (e.g., 90°+/−5°, 90°+/−10°, 90°+/−15°, or 90°+/−20°) tothe major diameter 108 of the oval shaped main body 106. In someembodiments, the valve 100 can also include one or more leafletengagement members 140 (e.g., refer to FIG. 16-23 ) that extend along adirection that is transverse (or substantially orthogonal) to the majordiameter 108 of the oval shaped main body 106 in the same direction asthe posterior flap 130.

In some embodiments, as depicted in FIG. 40 , the main body 106 issmaller than the full size/area of the annulus 12. Accordingly, theanterior flaps 120 a-b can be used to fill up the internal area definedthe annulus 12 that is not occupied by the main body 106. The occluder110 occupies a circular cross-sectional shape that is smaller than themain body 106, which is adequate for the hemodynamics of the blood flowbetween the atrium and the ventricle. In some embodiments, thepercentage of the internal area defined by the annulus 12 that isoccupied by the main body 106 is about 50% (with the remaining about 50%of the area of the annulus 12 being covered by the anterior flaps 120a-b). In some embodiments, the percentage of the area of the annulus 12that is occupied by the main body 106 is in a range of about 50% to 60%,or 55% to 65%, or 60%, to 70%, or 65% to 75%, or 70% to 80%, or 75% to85%, or 60% to 80%, without limitation, with the anterior flaps 120 a-bcovering the remainder of the area of the annulus 12. In someembodiments, the anterior flaps 120 a-b cover at least 50%, or at least40%, or at least 30%, or at least 20%, or at least 10%, or at least 5%of the internal area defined by the annulus 12.

The fact that the anterior flaps 120 a-b cover at least a portion of thearea of the annulus 12 can be beneficial for additional reasons. Forexample, if, at some point in the future after the valve 100 has beenimplanted in the annulus 12, a pacemaker lead needs to be passed throughthe annulus 12, then a location on the anterior flaps 120 a-b can bepunctured to allow the pacemaker lead to pass through the anterior flaps120 a-b. The puncture can be at the open passage 122, or at anotherlocation of the anterior flaps 120 a-b. The ability to pass a pacemakerlead through the anterior flaps 120 a-b is advantageous because doing sodoes not affect the functionality of the occluder 110. This is advantageis made possible by the fact that the anterior flaps 120 a-b cover atleast a portion of the area of the annulus 12.

Since, as depicted in the example of FIG. 40 , in some cases a portionof the oval shaped annulus 12 is covered by the anterior flaps 120 a-b,the main body 106 need not be circular, and can be constructed to havevarious types of cross-sectional shapes. An oval shape (as shown) may bepreferable in some cases, as it can be radially compressed well forfitting in a low-profile delivery catheter because it can have a smallerperimeter due to the minor diameter 109 of the main body 106 beingshorter than the major diameter 108. If, for example, the main body 106had a circular cross-sectional shape with a diameter equal to the majordiameter 108, the main body 106 could not be radially crushed/compressedto as small of a size as the depicted oval shaped main body 106. Hence,a larger delivery sheath would be required if the main body 106 wascircular (as compared to ovular as shown).

Interestingly, in the example depicted in FIG. 40 , while both theannulus 12 of the tricuspid valve 10 and the main body 106 of the valve100 are oblong or oval shaped, the orientations of their major and minordiameters are about 90° (e.g., 90°+/−10°) offset in relation to eachother when the valve 100 is implanted in the tricuspid valve 10. Thatis, the major diameter 108 of the oval shaped main body 106 issubstantially parallel (e.g., +/−10°) relative to the minor diameter 18of the annulus 12. Moreover, the minor diameter 109 of the oval shapedmain body 106 is substantially parallel (e.g., +/−10°) relative to themajor diameter 16 of the annulus 12. These geometric relationships arebeneficial because the annulus 12 is fully occluded by the valve 100 andthe diameter of the radially compressed delivery configuration of thevalve 100 can be reduced (as compared to having the main body 106filling a larger area of the annulus 12).

Again, it is evident in FIG. 40 that the opening defined by the nativeannulus 12 is not completely filled by the main body 106. Instead, thelaterally-extending first and second anterior flaps 120 a-b help tocover and fluidly seal the native tricuspid valve opening which is notcircular in this example (e.g., with the native valve opening beingoblong, or irregularly shaped). In other words, in combination with themain body 106 of the valve 100, the first and second anterior flaps 120a-b (and the laterally-extending posterior anchoring flap 130 in somecases) help to cover and fluidly seal the native tricuspid valve openingwhich is not circular in some cases. In addition, terminal end portionsof the first and second anterior flaps 120 a-b extend into the RVOT toprovide anchoring and migration resistance. Accordingly, the first andsecond anterior flaps 120 a-b perform both sealing and anchorage.

The configuration of the valve 100 with its oval shaped main body 106and its first and second anterior flaps 120 a-b that extend alongdirections that are transverse to the major diameter 108 (e.g.,substantially orthogonally) can be advantageous for multiple reasons.For example, as shown in FIG. 40 , while the entirety of space withinthe native annulus 12 is occluded by the valve 100, a significantportion of the occlusion is provided by the first and second anteriorflaps 120 a-b. This is advantageous because the first and secondanterior flaps 120 a-b can be radially compressed to a smaller deliveryprofile than the more substantial frame 102 of the main body 106. Thatis the case because the first and second anterior flaps 120 a-b havefewer components of the frame 102 than the main body 106. In addition,as shown in FIGS. 24-26 , the first and second anterior flaps 120 a-bcan be longitudinally spaced away from the main body 106 when collapsedin the delivery catheter/sheath 200. Since these portions are notradially “stacked” together in the delivery catheter/sheath 200, thisfacilitates their ability to be compressed into a smaller deliverycatheter/sheath 200.

Hence, for at least the reasons described above, the valve 100 can beadvantageously delivered and deployed via a smaller diameter deliverycatheter/sheath as a result of the depicted design of the valve 100. Inaddition, the oval shaped main body 106 (with its minor diameter 109)has a smaller outer periphery (e.g., as compared to if the main body 106was made with a circular cross-section having a diameter equal to itsmajor diameter 108). The comparative reduction in the bulk of the frame102 of the main body 106 enables the valve 100 to be radially compressedto a smaller delivery profile. This is another structural reason thatallows the valve 100 to be advantageously delivered and deployed via asmaller diameter delivery sheath/catheter as a result of the depicteddesign of the valve 100.

In some cases, the shape of a patient's native annulus 12 is generallycircular. In such a case, the valve 100 can still provide much of thebenefits described above. For example, the main body 106 can still havean ovular outer cross-sectional shape that occupies less than the fullcircular area of the native annulus 12 (with the first and secondanterior flaps 120 a-b occupying the remainder). In that case, the valve100 is implanted in the native annulus 12 such that the central axis 101of the occluder 110 is laterally offset (e.g., in the posteriordirection) from the geometric center of the generally circular nativeannulus 12. In addition, the major diameter 108 of the main body 106 canbe shorter than the diameter of the native annulus 12. For example, insome embodiments the length of the major diameter 108 of the main body106 is about 60% to 80% of the diameter of the native annulus 12, orabout 70% to 90% of the diameter of the native annulus 12, or about 80%to 95% of the diameter of the native annulus 12, without limitation.

FIG. 41 illustrates a frame 102 that is shaped like the frame of theschematically depicted valve 100 of FIG. 40 . The illustrated frame 102has the main body 106 with the oval shaped outer profile. The ovalshaped outer profile defines the major diameter 108 and the minordiameter 109. The occluder 110 has a circular cross-sectional shape.

FIG. 42 shows a covering 104 on the frame 102 of FIG. 41 . The openings126 a-b in the end portions of the anterior flaps 120 a-b are alsoshown. It can be seen that, in some embodiments, at least some portionsof the openings 126 a-b align and overlap each other.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment in part or in whole. Conversely,various features that are described in the context of a singleembodiment can also be implemented in multiple embodiments separately orin any suitable subcombination. Moreover, although features may bedescribed herein as acting in certain combinations and/or initiallyclaimed as such, one or more features from a claimed combination can insome cases be excised from the combination, and the claimed combinationmay be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Although a number of implementations have been described indetail above, other modifications are possible. For example, the logicflows depicted in the figures do not require the particular order shown,or sequential order, to achieve desirable results. In addition, othersteps may be provided, or steps may be eliminated, from the describedflows, and other components may be added to, or removed from, thedescribed systems. Accordingly, other implementations are within thescope of the following claims.

What is claimed is:
 1. A prosthetic heart valve comprising: a main bodycomprising an inflow end portion and an outflow end portion; an occluderextending between the inflow end and outflow end portions and defining alongitudinal axis, the occluder comprising valve leaflets attached tothe main body in an arrangement that: (i) allows blood flow through theoccluder in a direction from the inflow end portion toward the outflowend portion and (ii) prevents blood flow through the occluder in adirection from the outflow end portion toward the inflow end portion; aposterior flap extending from the main body; and a leaflet engagementmember extending from the main body, a portion of the leaflet engagementmember extending toward the inflow end portion and terminating at a freeend.
 2. The prosthetic heart valve of claim 1, wherein the posteriorflap extends farther away from the main body than the leaflet engagementmember.
 3. The prosthetic heart valve of claim 1, wherein an area of themain body that the leaflet engagement member extends from is the outflowend portion or a mid-body portion located between the inflow end andoutflow end portions.
 4. The prosthetic heart valve of claim 1, furthercomprising a first anterior flap and a second anterior flap extendingaway from the outflow end portion of the main body and away from theposterior flap.
 5. The prosthetic heart valve of claim 4, whereinportions of the first anterior flap and the second anterior flap areconfigured to overlap each other when the prosthetic heart valve isdeployed.
 6. The prosthetic heart valve of claim 5, wherein an openspace is defined between the first anterior flap and the second anteriorflap when the prosthetic heart valve is deployed.
 7. The prostheticheart valve of claim 4, wherein the first and second anterior flaps eachinclude a mid-body portion that is bent at an angle that directsterminal end portions of each of the first and second anterior flapspartially toward the inflow end of the main body.
 8. The prostheticheart valve of claim 7, wherein the angle is between 20° and 60°.
 9. Theprosthetic heart valve of claim 4, further comprising a coveringattached to the first and second anterior flaps, wherein the coveringdefines a first opening through a terminal end portion of the firstanterior flap, and wherein the covering defines a second opening througha terminal end portion of the second anterior flap.
 10. A prostheticheart valve comprising: a main body comprising an inflow end portion andan outflow end portion; an occluder extending between the inflow end andoutflow end portions and defining a longitudinal axis, the occludercomprising valve leaflets attached to the main body in an arrangementthat: (i) allows blood flow through the occluder in a direction from theinflow end portion toward the outflow end portion and (ii) preventsblood flow through the occluder in a direction from the outflow endportion toward the inflow end portion, the occluder having a circularcross-sectional shape; and an anterior flap extending from the mainbody, wherein the anterior flap includes a mid-body portion that is bentat an angle that directs a terminal end portion of the anterior flappartially toward the inflow end of the main body.
 11. The prostheticheart valve of claim 10, wherein the angle is between 20° and 60°. 12.The prosthetic heart valve of claim 10, wherein the anterior flap is afirst anterior flap, and wherein the prosthetic heart valve furthercomprises a second anterior flap extending along the first direction andaway from the outflow end portion of the main body.
 13. The prostheticheart valve of claim 12, wherein portions of the first anterior flap andthe second anterior flap are configured to overlap each other when theprosthetic heart valve is deployed.
 14. The prosthetic heart valve ofclaim 13, wherein an open space is defined between the first anteriorflap and the second anterior flap when the prosthetic heart valve isdeployed.
 15. The prosthetic heart valve of claim 10, further comprisinga covering attached to the anterior flap, wherein the covering definesan opening through the terminal end portion of the anterior flap.
 16. Aprosthetic heart valve comprising: a main body comprising an inflow endportion and an outflow end portion; an occluder extending between theinflow end and outflow end portions and defining a longitudinal axis,the occluder comprising valve leaflets attached to the main body in anarrangement that: (i) allows blood flow through the occluder in adirection from the inflow end portion toward the outflow end portion and(ii) prevents blood flow through the occluder in a direction from theoutflow end portion toward the inflow end portion; an anterior flapextending from the main body; and a covering attached to the anteriorflap, wherein the covering defines an opening.
 17. The prosthetic heartvalve of claim 16, wherein the anterior flap includes a mid-body portionthat is bent at an angle that is between 20° and 60° and that directsthe terminal end portion of the anterior flap partially toward theinflow end of the main body.
 18. The prosthetic heart valve of claim 16,wherein the anterior flap is a first anterior flap and the opening is afirst opening, and wherein the prosthetic heart valve further comprisesa second anterior flap extending from the main body.
 19. The prostheticheart valve of claim 18, wherein the covering is attached to the secondanterior flap, and wherein the covering defines a second opening throughthe second anterior flap.
 20. The prosthetic heart valve of claim 19,wherein at least some portions of the first and second openings alignand overlap each other when the prosthetic heart valve is deployed.